EMS SWISS ORTHOCLAST

K991588 · (Ems Sa) Electro Medical Systems · HSZ · Jul 21, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991588
• Device Name: EMS SWISS ORTHOCLAST
• Applicant: (Ems Sa) Electro Medical Systems
• Product Code: HSZ · General, Plastic Surgery
• Decision Date: Jul 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The EMS Swiss OrthoClast® is used for the removal of cement during implant revision surgery.

Device Story

The Swiss OrthoClast® is a pneumatic-powered orthopedic surgical instrument used for bone cement removal during implant revision surgery. The system comprises a pressure regulator/control unit, pneumatic footswitch, handpiece, various chisels, a hollow drill/extractor for cement tips, and an Orthoscope. Operation involves a pressure pulse from the control unit driving an internal projectile within the handpiece to strike the chisel; this generates a shock wave causing high-speed, short-excursion tip movement to fragment bone cement. The Orthoscope provides direct visualization of body cavities (e.g., femoral cavity). The device is operated by a surgeon in a clinical setting, requiring only one hand to operate, which allows for precise guidance of the chisel tip. The intermittent pulse mechanism prevents heat build-up at the fragmentation site. The device benefits the patient by facilitating efficient cement removal during revision procedures.

Clinical Evidence

Bench testing only. Testing included risk analysis, maximum chisel tip excursion and velocity measurements, handpiece and chisel longevity testing, in vitro cement fragmentation efficiency, and Orthoscope temperature elevation monitoring. Results confirmed design objectives were met.

Technological Characteristics

Pneumatic-powered orthopedic surgical instrument. System includes pressure regulator, pneumatic footswitch, handpiece, and various steel chisels. Operates via ballistic principle: pneumatic pressure pulse drives internal projectile to strike chisel, creating shock waves. Includes fiberoptic-style Orthoscope for visualization. No software or electronic algorithms; purely mechanical/pneumatic operation.

Indications for Use

Indicated for patients undergoing implant revision surgery requiring the removal of bone cement.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• Ceboplane® (K933933)

Submission Summary (Full Text)

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91588

# 510(k) Summary . for Swiss OrthoClast®

#### 1. SPONSOR

EMS SA Ch. de la Vuarpillière 31 CH-1260 Nyon Switzerland

| Contact Person: | Gianni Campana |
|-----------------|-------------------|
| Telephone: | 011 41 22 9944770 |

May 5, 1999 Date Prepared:

#### 2. DEVICE NAME

Swiss OrthoClast® Proprietary Name: Powered orthopedic surgical instrument Common/Usual Name: Instrument, surgical, orthopedic, pneumatic powered and Classification Name: accessories

#### 3. PREDICATE DEVICE

Ceboplane® (K933933)

#### 4. INTENDED USE

The Swiss OrthoClast® is used for the removal of bone cement during implant revision surgery.

#### 5. DEVICE DESCRIPTION

The EMS Swiss OrthoClast® system consists of a pressure regulator/control unit, pneumatic footswitch, handpiece, chisels of various sizes and shapes, a hollow drill and extractor for removal of the cement tip, and the Orthoscope. The Swiss OrthoClast® uses simple pneumatic and ballistic principles to fragment bone cement. A pressure pulse generated by the pressure regulator/control unit causes a moveable projectile in the handpiece to be driven forward to strike the proximal end of the chisel. The impact generates a shock wave along the chisel, which leads to a small, high-speed excursion of the chisel tip. The distal end of the chisel is

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held in contact with the targeted cement. Repetitive shock waves result in fragmentation of the bone cement. A short tip excursion period followed by a longer rest period prevents the build-up of heat in the fragmentation site. Direct vision into body cavities, such as the femoral cavity, is facilitated using the Orthoscope.

### 6. PERFORMANCE TESTING

A comprehensive risk analysis was conducted to identify potential hazards associated with the use and misuse of the Swiss OrthoClast®. Verification tests conducted as a result of this risk analysis include the following

- Maximum excursion and velocity of the Swiss OrthoClast® chisel tips ●
- Handpiece and chisel longevity
- In vitro cement fragmentation efficiency .
- . Orthoscope temperature elevation

The results of these tests confirmed that the Swiss OrthoClast® met the design objectives as identified by the risk analysis.

## 6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The Swiss OrthoClast® has the same intended use as the Ceboplane®, that is, removal of bone cement during implant revision surgery. The Ceboplane® is a pneumatic powered reciprocating handpiece that accepts a wide variety of osteotome chisels. A fiberoptic illuminator mounts directly on the predicate handpiece to enhance visualization for working in deep cavities. Like the Swiss OrthoClast®, the Ceboplane® uses an internal piston hammer to deliver a highenergy, short-excursion impact to the desired location under the guidance of the surgeon using either single or multiple pulse mode. Both the OrthoClast® and the Ceboplane® require only one hand to operate, unlike the traditional osteotome and mallet which require two hands, allowing the surgeon to focus on the impact sight and precisely guide the chisel tip to its optimum position.

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JUL 2 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Shelia Hemeon-Heyer, Esq., RAC Senior Staff Consultant MDCI Representing EMS SA 49 Plain Street North Attleboro, Massachusetts 02760

Re: K991588 Trade Name: Swiss OrthoClast® Regulatory Class: II Product Code: HSZ, LZV, and GET Dated: May 5, 1999 Received: May 7, 1999

Dear Ms. Hemeon-Heyer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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# Page 2 - Ms. Shelia Hemeon-Heyer

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K 991588

Device Name: EMS Swiss OrthoClast®

Indications For Use:

The EMS Swiss OrthoClast® is used for the removal of cement during implant revision surgery.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sian-Off) Division of General Restorative Devi Kgg1598 510(k) Number

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)